Apply to Trial

Compensation: Varies

Number of Visits: 1

146 Participants Needed

Contrast-Enhanced Ultrasound for Abdominal Injuries

Overseen ByRachel Rempell, MD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Allergy to Lumason, Heart disease, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] for abdominal injuries?

Research shows that Lumason, which contains sulfur hexafluoride microbubbles, is effective in characterizing liver lesions, suggesting it may also be useful in identifying abdominal injuries. This treatment is widely used in Europe and Asia, and studies indicate it has high sensitivity and specificity, meaning it is good at correctly identifying conditions.¹ ² ³ ⁴ ⁵

How does the treatment Contrast-Enhanced Ultrasound for Abdominal Injuries differ from other treatments?

Contrast-Enhanced Ultrasound (CEUS) uses sulfur hexafluoride microbubbles to enhance ultrasound images, making it unique compared to other imaging techniques like CT or MRI, which do not use microbubbles. This method is non-invasive and provides real-time imaging, which can be particularly useful for assessing abdominal injuries.¹ ² ³ ⁵ ⁶

What is the purpose of this trial?

Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.

Research Team

Aaron E Chen, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for children who may have internal injuries from blunt force to the belly. They must be stable enough not to need immediate surgery or a massive blood transfusion, and they should already be scheduled for or have had a CT scan. Kids with allergies to Lumason ingredients, heart disease, or penetrating abdominal wounds can't join.

Inclusion Criteria

I have had or might have had a blunt injury to my abdomen.

I have had or will have a CT scan of my abdomen.

I am not in need of an emergency blood transfusion or surgery within the next hour.

Exclusion Criteria

I am allergic to Lumason or its components.

I have a known heart condition from birth or acquired later.

Co-existing penetrating abdominal trauma

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Evaluation

Participants undergo contrast-enhanced ultrasound (CEUS) and conventional CT scan for evaluation of intra-abdominal organ injury

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of imaging techniques after initial evaluation

4 weeks

Treatment Details

Interventions

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]

Trial Overview The study is testing if contrast-enhanced ultrasound using LUMASON can spot internal organ damage in kids with belly injuries as an alternative to CT scans. This could avoid radiation exposure and be done right at the bedside without moving the child.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Contrast-enhanced ultrasound armExperimental Treatment2 Interventions

contrast-enhanced ultrasound

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Findings from Research

Lumason (sulfur hexafluoride microbubbles) has recently been FDA approved for characterizing focal liver lesions (FLL) in both pediatric and adult patients, which is expected to increase its use in routine clinical practice.

The literature indicates that contrast-enhanced ultrasound (CEUS) using Lumason is accurate for FLL characterization, with existing studies comparing its effectiveness to contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance imaging (CEMRI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast enhanced ultrasound for focal liver lesions: how accurate is it?Barr, RG.[2019]

The study developed new microbubbles using lipids and sulfur hexafluoride (SF6) that significantly enhance the echogenicity of thrombi, improving their visibility during ultrasound imaging.

These targeted microbubbles demonstrated high stability and maintained their characteristics for up to 8 hours, providing a longer diagnostic window compared to traditional nontargeted microbubbles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonging the ultrasound signal enhancement from thrombi using targeted microbubbles based on sulfur-hexafluoride-filled gas.Wang, B., Zang, WJ., Wang, M., et al.[2016]

The FDA has approved Lumason, a contrast agent for ultrasound, which is expected to enhance the characterization of focal liver lesions in both adults and children, promoting the use of contrast-enhanced ultrasound (CEUS) in clinical practice.

The paper outlines essential guidelines for establishing a CEUS program, including safety measures, indications, contraindications, and procedures for performing and interpreting CEUS exams, ensuring efficient and safe implementation in ultrasound departments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Develop a Contrast-Enhanced Ultrasound Program.Barr, RG.[2018]